Some things change, some remain the same. Following last week's mid-term elections in the U.S., the biggest challenge to new drug development in Washington remains the same as it was under Republican leadership: regulatory reform.
What has changed is the likelihood that things won't go well. Indeed, after a nine-year run of efforts to stimulate regulatory innovations that support therapeutic innovation, the tide looks to be moving even more toward the agenda of regulatory reformers whose nostrums to protect the public arguably would delay or prevent new treatments from reaching the bedside.
The mid-term elections have resulted in three key shifts. Two are obvious: the Democrats control both houses of Congress, while some important industry supporters from the Republican Party will be gone when the 110th Congress convenes in January.
Less widely appreciated - but probably equally important - is the strengthening of a broad swath of both Republicans and many freshman Democrats who represent the populist streak that has long run through American politics.
Many of the freshman Democrats, especially in the House, are as conservative as the Republicans they defeated and are united with more liberal incumbents by little more than criticism of the conduct of the war in Iraq.
On the other hand, economic populism is one perspective that most of the newly minted members of Congress share with other members of their caucus - and importantly with a like-minded collective of their Republican counterparts.
Even if Sen. Charles Grassley (R-Iowa) is no longer a committee chairman, many of these lawmakers look prepared to continue his campaign to protect the little guy against price gouging and an industry